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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05080868
Other study ID # 2019PI221
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2021
Est. completion date August 15, 2021

Study information

Verified date October 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its clinical history. Absent at birth or present under the form of a premonitory mark, they display a rapid proliferative phase starting in the first weeks of life. Then, after a plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma has been recently described and data are lacking regarding its proportion among infantile hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive hemangioma.


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date August 15, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Children between 0 and 18 years old - Followed in the dermatology department of CHRU de Nancy between January 2014 and December 2020 - Presenting with one or more infantile hemangioma Exclusion Criteria: - Those whoes guardian does not want his data to be collected in this study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Nancy Nancy Grand-Est

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of abortive hemangioma among infantile hemangioma Proportion of abortive hemangioma among infantile hemangioma baseline
Secondary To compare the epidemiological characteristics between infantile hemangioma and abortive hemangioma : sex Compare sex predominance between infantile hemangioma and abortive hemangioma baseline
Secondary To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : prematurity Compare prematurity rates between infantile hemangiomas and abortive hemangiomas baseline
Secondary To compare the epidemiological characteristics between infantile hemangiomas and abortive hemangiomas : birthweight Compare birthweight between infantile hemangiomas and abortive hemangiomas baseline
Secondary To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : localization Compare localization between infantile hemangiomas and abortive hemangiomas baseline
Secondary To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : treatment le hemangiomas and abortive hemangiomaCompare treatment between infanti baseline
Secondary To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : complications Compare complications between infantile hemangiomas and abortive hemangioma baseline
Secondary To compare the clinical characteristics between infantile hemangiomas and abortive hemangiomas : size Compare size (focal, extended or segmental) between infantile hemangiomas and abortive hemangioma baseline
Secondary To study the evolution of abortive hemangioma : erythematous macule Evaluation of the fading of erythematous macule between the stage of maximal proliferation and the last follow-up through study completion, an average of 4 years
Secondary To study the evolution of abortive hemangioma : papules of proliferation Evaluation of the regression of the papules of proliferation between the stage of maximal proliferation and the last follow-up through study completion, an average of 4 years
Secondary To study the evolution of abortive hemangioma : telangiectasias Evaluation of the fading of telangiectasias between the stage of maximal proliferation and the last follow-up through study completion, an average of 4 years
Secondary To study the evolution of abortive hemangioma : halo of vasoconstriction Evaluation of the fading of the vasoconstricted halo between the stage of maximal proliferation and the last follow-up through study completion, an average of 4 years
Secondary To study the evolution of abortive hemangioma : areas of vasoconstriction Evaluation of the fading of vasoconstricted areas between the stage of maximal proliferation and the last follow-up through study completion, an average of 4 years
Secondary To study the evolution of abortive hemangioma : dilated veins Evaluation of the fading of dilated veins between the stage of maximal proliferation and the last follow-up through study completion, an average of 4 years
See also
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Completed NCT00601016 - A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy Phase 2